Patient Registry of Blind Subjects With Sleep-related Problems

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by Vanda Pharmaceuticals
Sponsor:
Information provided by (Responsible Party):
Vanda Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01195558
First received: September 2, 2010
Last updated: June 18, 2014
Last verified: June 2014
  Purpose

Non-24-hour sleep-wake disorder (Non-24) is a condition experienced primarily by totally blind individuals that results in abnormal night sleep patterns and chronic daytime sleepiness. This is a research protocol to develop a patient registry of subjects who may suffer from Non-24 and who are blind. Subjects participate in the study through a phone survey. This registry will be used to better understand, sleep related problems in blind individuals, including the investigation of a potential treatment, recruitment for future clinical studies, and to provide a forum for raising awareness about Non-24. The survey consists of questions regarding the degree of vision impairment and sleep problems that the subjects may be experiencing.


Condition Intervention
Sleep-wake Disorder in Blind Individuals
Other: Data collection on blindness and sleep problems

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: Development of a Patient Registry of Blind Subjects With Sleep-related Problems

Resource links provided by NLM:


Further study details as provided by Vanda Pharmaceuticals:

Primary Outcome Measures:
  • Number of blind participants [ Time Frame: ongoing ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Sleep/wake disruptions [ Time Frame: ongoing ] [ Designated as safety issue: No ]

Estimated Enrollment: 10000
Study Start Date: April 2010
Estimated Primary Completion Date: April 2030 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Blind with sleep problems
Blind individuals with no light perception and with sleep-related problems who may suffer from Non-24
Other: Data collection on blindness and sleep problems
Data related to degree of vision impairment and sleep problems is collected through a phone or web survey
Other Name: Data Collection

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

General population of blind individuals

Criteria

Inclusion Criteria:

  1. Subjects or legal guardians must be at least 18 years of age to participate in the telephone survey. Parents or legal guardians may represent children from 0 through 17 years who meet the following criteria.
  2. Subjects must be blind.
  3. Subjects must have some self-described problem with sleep or daytime sleepiness.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01195558

Contacts
Contact: Vanda Pharmaceuticals 1-844-361-2424

Locations
United States, District of Columbia
Vanda Pharmaceuticals Recruiting
Washington, District of Columbia, United States, 20037
Contact    844-361-2424      
Sponsors and Collaborators
Vanda Pharmaceuticals
Investigators
Principal Investigator: Seth Smith, Pharm.D., MBA Vanda Pharmaceuticals
  More Information

No publications provided

Responsible Party: Vanda Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01195558     History of Changes
Other Study ID Numbers: Pro00005099
Study First Received: September 2, 2010
Last Updated: June 18, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Vanda Pharmaceuticals:
Non-24
N24HSWD
Blindness
Sleep
Wake
Circadian Rhythm
Nap

ClinicalTrials.gov processed this record on September 18, 2014